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Pilot Study of High-Dose Capsaicin Patches to Treat Postherpetic Neuralgia Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00034710
Recruitment Status : Completed
First Posted : May 2, 2002
Last Update Posted : February 7, 2006
Information provided by:

Brief Summary:
The purpose of this study is to gain initial information on the tolerability of high-dose capsaicin patches in patients with Painful Postherpetic Neuralgia. The study will also collect preliminary information on safety and efficacy.

Condition or disease Intervention/treatment Phase
Neuralgia Pain Peripheral Nervous System Diseases Herpes Zoster Drug: Capsaicin Patch Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 42 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind Controlled Pilot Study of High-Dose Capsaicin Patches in the Treatment of Pain Associated With Postherpetic Neuralgia
Study Start Date : March 2002
Study Completion Date : October 2002

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Shingles
MedlinePlus related topics: Shingles
Drug Information available for: Capsaicin

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Eligibility Criteria

Inclusion Criteria:

Patients may be eligible for this study if they:

  • Have a diagnosis of Painful Postherpetic Neuralgia and are at least 6 months post vesicle crusting.
  • Are in good health.
  • Have an adequate pain score during the screening period.
  • Have painful areas (maximum of two sites) below the neck.
  • If female, are of non-childbearing ability as defined by absence of menses for a minimum of 3 months or surgically sterile.
  • If male, are willing to agree to take adequate birth control precautions with their partner for 60 days following experimental drug exposure.
  • Have unbroken skin with good perfusion over the painful area(s).
  • Have the ability to feel capsaicin-mediated sensations, as evidenced by ability to feel topically applied OTC capsaicin cream.
  • Are on a stable and continuous medication regimen, with no change in dosage for 21 days prior to study start, and are willing to maintain concomitant medications at current doses throughout the study.
  • Are willing and able to use oral opioid-based analgesic agents for relief, in case this is needed to relieve acute pain associated with the application of capsaicin patches.
  • Are 18 years of age or older.
  • Are willing and able to comply with the protocol

Exclusion Criteria:

Patients will not be eligible for this study if they:

  • Have diffusely distributed neuropathic pain (i.e., pain that is evident in more than 2 different sites). Subjects must not have significant pain outside the areas to be treated.
  • Have any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain.
  • Currently (within the past 21 days) use topically applied non-steroidal anti-inflammatory drugs, local anesthetics, steroids or capsaicin products on the painful areas.
  • Currently (within the past 21 days) use topical agents such as lidoderm patch 5%, topical steroids or aspirin.
  • Have a history or current problem with prescription drug or illicit substance abuse (from self report or as judged by investigator).
  • Currently have an abuse problem with alcohol (from self-report or as judged by investigator).
  • Are suspected of psychosocial gain/benefit of continued pain as judged by the investigator or primary treating physician.
  • Plan to travel more than 100 miles from home during the study or engage in unusual activities that might exacerbate pain.
  • Have poor cardiac, renal, hepatic, or pulmonary function judged by the investigator or primary treating physician.
  • Have a laboratory value at screening outside the normal range, unless it is judged by the investigator as not clinically significant after appropriate evaluation.
  • Have hypersensitivity to capsaicin (i.e., chili peppers or OTC capsaicin products), local anesthetics, oral opioid-based analgesic agents, or adhesives.
  • Have a high tolerance to opioids.
  • Currently using Class 1 anti-arrhythmic drugs (such as tocainide and mexiletine).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00034710

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United States, Arizona
Arizona Research Center
Phoenix, Arizona, United States, 85023
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
United States, Florida
Anchor Research Center
Naples, Florida, United States, 34102
Palm Beach Neurological Center
Palm Beach Gardens, Florida, United States, 33410
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, United States, 33701
United States, Massachusetts
Brigham and Women's Hospital, Pain Trials Center
Boston, Massachusetts, United States, 02115
United States, Utah
University of Utah Pain Management Center
Salt Lake City, Utah, United States, 84108
United States, Wisconsin
University of Wisconsin Hospital, Neurology Department
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
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Study Director: John A Jermano NeurogesX
Layout table for additonal information Identifier: NCT00034710    
Other Study ID Numbers: C102
First Posted: May 2, 2002    Key Record Dates
Last Update Posted: February 7, 2006
Last Verified: February 2006
Keywords provided by NeurogesX:
Analgesics/*therapeutic use
Capsaicin/*administration & dosage/adverse effects
Herpes Zoster/*complications/drug therapy
Neuralgia/*drug therapy/etiology
Dermal assessment
Pain measurement
Postherpetic Neuralgia
Additional relevant MeSH terms:
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Herpes Zoster
Nervous System Diseases
Neuralgia, Postherpetic
Peripheral Nervous System Diseases
Neuromuscular Diseases
Neurologic Manifestations
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs